OneTouch® Verio™Pro+ Blood Glucose Monitoring System Clinical Accuracy Study in China

A Multi-centre, Open Clinical Evaluation to Determine Professional Clinical Accuracy Comparing the OneTouch® Verio™Pro+ Blood Glucose Results With the YSI 2300 Analyzer.

The evaluation will determine professional clinical accuracy comparing the OneTouch® Verio™Pro+ blood glucose results with the YSI 2300 analyzer. "Professional Clinical Accuracy" is defined as accuracy of the system when used by a trained healthcare professional.

Study Overview

• Status: Completed
• Conditions: Blood Glucose Measurement

• Study Type: Observational
• Enrollment (Actual): 301

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai First People's Hospital
  • Shanghai, China
    • Shanghai Jiaotong University, medical school affiliated Third People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of at least 240 diabetic subjects (type 1 or type 2) study-wide at two clinical sites.

Description

Inclusion Criteria:

• Subject is at least 18 years of age.
• Subject has been diagnosed with diabetes mellitus (type 1 or type 2 diabetes)
• Subject agrees to sign two (2) copies each of the Subject Informed Consent Form and to follow the procedures of the study.
• Subject agrees to allow the HCP to perform finger stick for blood glucose test by the meter and the YSI instrument. Up to one retry of finger stick will be needed in the event of insufficient blood collected or test failure.
• Subject agrees to allow the HCP to perform venous puncture for blood glucose test by the meter and the YSI instrument, and for haematocrit (HCT) test. Up to one retry of venous puncture will be needed in the event of insufficient blood collected or test failure.
• Subject agrees to provide demographic and medical history information and give access to medical records where appropriate.

Exclusion Criteria:

• Subject is currently working for, has previously worked for, or has an immediate family member working for a company manufacturing and/or marketing blood glucose monitoring products.
• Subject has already participated in this study.
• Subject is known pregnant

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Obtain professional clinical accuracy data for the OneTouch® Verio™Pro+ blood glucose monitoring meter in comparison with a standard laboratory reference (YSI 2300 glucose analyzer) using a capillary blood sample and a venous sample	August 20,2012~October 14,2012	56days

Collaborators and Investigators

• Sponsor: Johnson & Johnson Medical, China
• Investigators: Principal Investigator: Yongde Peng, Professor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Principal Investigator: Fengling Chen, Professor, Shanghai Jiaotong University, medical school affiliated Third People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2012
• Primary Completion (Actual): October 31, 2012
• Study Completion (Actual): October 31, 2012

Study Registration Dates

• First Submitted: February 18, 2013
• First Submitted That Met QC Criteria: February 18, 2013
• First Posted (Estimated): February 20, 2013

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LFS-201201